Novartis’ new therapy for neovascular age-related macular degeneration (nAMD) has advanced part-way through the European regulatory process after winning the approval of independent advisors.
On 12 December, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorisation for Beovu (brolucizumab 6 mg).
It comes after the anti-VEGF therapy received its first market approval by the US Food and Drug Administration in October.
“[The] CHMP opinion brings us another step closer to providing wet AMD patients in Europe with a new treatment option,” said Mr Nikos Tripodis, Novartis’ worldwide franchise head of ophthalmology.
“At Novartis, we remain committed to reimagining treatments for patients suffering from wet AMD, a leading cause of blindness worldwide.”
Beovu is now the third major player to enter the global anti-VEGF market to treat nAMD. It competes with Roche’s Lucentis, the pioneering anti-VEGF treatment that is also sold by Novartis in markets outside the US.
It will become the main rival to Bayer/Regeneron’s Eylea (aflibercept), which has established itself as the market-leading therapy since its launch in 2011. Last year the drug generated US$6.75 billion (AU$9.83 b) in global revenue.
Beovu and Eylea have already gone head-to-head in two key clinical trials (Hawk and Harrier) and have shown comparable results.
A key factor in nAMD treatment is the frequency of treatment. The recommended dose for Beovu is three initial monthly injections, followed by one treatment every 8-12 weeks. Eylea’s recommended regimen is three monthly injections, followed by a treatment every eight weeks thereafter.
A treat-and-extend dosing regimen has also been approved for Eylea, meaning some patients may be eligible for treatments every 12 weeks or more.
According to Novartis, 56% of patients in Hawk and 51% in Harrier treated with Beovu 6mg maintained a three-month dosing interval immediately after the loading phase through year one.
The CHMP stated that a key benefit with Beovu is its ability to preserve visual acuity, demonstrated throughout two years of treatment.
“The most common side effects are conjunctival haemorrhage and eye pain as well as intraocular inflammation and retinal artery occlusive events,” the committee concluded.
The European Commission will consider the CHMP opinion as it makes its final decision on the marketing authorisation. The decision is expected within three months.